PREcision Event Monitoring of PatienTs with Heart Failure

PREcision Event Monitoring of PatienTs with Heart Failure - PREEMPT-HF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48493

Enrollment

120

Registered

2019-08-26

Start date

2019-12-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac arrest congestive heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws • Subject has a documented diagnosis of heart failure • Subject has a Boston Scientific CRT-D or ICD device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON • Subject has an active bipolar RV lead implant. • Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled

Exclusion criteria

Exclusion criteria: • Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD). • Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries). • Subject has a life expectancy of less than 12 months. • Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol.

Design outcomes

Primary

Measure	Time frame
Primary Objective The primary objective of the PREEMPT-HF study is to investigate the association between HF sensor data and 30-day HF readmissions.	—

Secondary

Measure	Time frame
Additional Objectives 1. Characterize HF sensor data for: o Association with risk for device VT/VF therapy o Phenomapping of HF events o Association with non-HF hospitalizations including cardiac non-HF events and non-cardiac events 2. Collect subject Sleep Incline Sensor data prior to and following reviewable clinical events 3. Link study data to third-party data, such as Center for Medicare and Medicaid Services (CMS) administrative claims (US only). Association of clinical study events and sensor data with other data sources will be investigated. Any study data linkage will abide by all applicable laws, regulations, and data use agreements, and patients will be consented accordingly.	—

Measure

Time frame

Additional Objectives 1. Characterize HF sensor data for: o Association with risk for device VT/VF therapy o Phenomapping of HF events o Association with non-HF hospitalizations including cardiac non-HF events and non-cardiac events 2. Collect subject Sleep Incline Sensor data prior to and following reviewable clinical events 3. Link study data to third-party data, such as Center for Medicare and Medicaid Services (CMS) administrative claims (US only). Association of clinical study events and sensor data with other data sources will be investigated. Any study data linkage will abide by all applicable laws, regulations, and data use agreements, and patients will be consented accordingly.

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Countries

Netherlands

Outcome results